QC Chemist I/II

Job Description

Job Description

About KVK Tech

KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.

What You’ll Do

The  QC Chemist I/II performs analytical testing of raw materials, in-process materials, finished products, and stability samples using approved, compendial, validated, or internal test methods.  This position may be filled at either QC Chemist I or QC Chemist II based on a combination of relevant professional experience, education, demonstrated technical proficiency, level of independence, instrumentation expertise, and experience with pharmaceutical Quality Control responsibilities . Placement will not be determined by years of experience or previous job title alone. QC Chemist I is intended for developing chemists capable of independently performing routine testing after qualification, while QC Chemist II is intended for experienced pharmaceutical laboratory professionals capable of handling complex testing, analytical troubleshooting, data review, investigations, and method-related activities with limited supervision.

Key Responsibilities:

• Perform analytical testing of raw materials, in-process samples, finished products, and stability samples using approved methods; Chemist I personnel primarily perform routine testing, while  Chemist II personnel perform both routine and complex analyses requiring greater technical judgment.

• Operate analytical instrumentation including HPLC, UPLC, GC, UV-Vis, dissolution equipment, Karl Fischer titrators, pH meters, balances, and related laboratory equipment based on demonstrated training, qualification, and assigned level.

• Prepare and standardize samples, reference solutions, reagents, buffers, and mobile phases while documenting all laboratory activities accurately and contemporaneously in accordance with cGMP, ALCOA, and Data Integrity requirements.

• Evaluate analytical results against established specifications and acceptance criteria; Chemist I personnel identify and promptly escalate atypical or potential OOS/OOT results, while Chemist II personnel independently interpret complex data, identify trends, and review peer-generated analytical documentation.

• Support laboratory investigations, method verification, validation, transfer, and troubleshooting activities;  Chemist II personnel are expected to independently execute assigned method activities, contribute to scientific root-cause analysis, and support deviations, CAPAs, and change controls.

• Perform assigned instrument calibrations, preventive maintenance, equipment readiness checks, and basic troubleshooting;  Chemist II personnel also provide technical guidance to less experienced chemists and support improvements to laboratory procedures and processes.

What We’re Looking For

Experience:

•  QC Chemist I : Typically requires 1–3 years of relevant professional analytical laboratory experience with a Bachelor’s degree. A candidate with a Master’s degree in Chemistry and no professional laboratory experience may also be considered for Level I based on demonstrated academic laboratory training and technical knowledge. A Bachelor’s degree without relevant professional laboratory experience will normally be considered at the QC Junior Chemist level.

•  QC Chemist II : Typically requires 3–6 years of progressively responsible analytical experience in a cGMP-regulated pharmaceutical Quality Control laboratory, including demonstrated independence in analytical testing, data interpretation, instrument troubleshooting, and GMP documentation.

•  Final level placement will be based on the complete qualifications of the candidate, including the relevance and quality of experience, education, independent proficiency with applicable instrumentation, complexity of testing performed, cGMP knowledge, data-review experience, investigation involvement, and method verification, validation, or transfer experience.  Meeting the stated number of years alone does not guarantee Level II placement.

Education:

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a closely related chemistry-based scientific discipline required.

•  Master’s degree in Chemistry may substitute for prior professional experience when determining eligibility for QC Chemist I;  an advanced degree alone does not qualify a candidate for QC Chemist II .

Skills & Knowledge:

•  QC Chemist I : Ability to independently perform routine analytical testing after qualification, prepare standards and samples, complete scientific calculations, operate commonly used laboratory instruments, and produce accurate, contemporaneous GMP documentation.

•  QC Chemist II : Advanced working proficiency with multiple analytical techniques such as HPLC, UPLC, GC, UV-Vis, dissolution, Karl Fischer titration, and wet chemistry, including the ability to troubleshoot instruments, interpret complex data, and review peer-generated laboratory records.

• Working knowledge of cGMP, GLP, USP requirements, ALCOA principles, Data Integrity expectations, and applicable laboratory controls; Chemist II candidates must demonstrate practical application of these requirements in a pharmaceutical QC environment.

• Experience with chromatographic data systems and laboratory documentation platforms such as Empower and LIMS, along with proficiency in Microsoft Excel, Word, and related applications.

• Strong attention to detail, scientific judgment, organization, communication, and ability to manage multiple testing assignments while maintaining laboratory safety, accuracy, and compliance.

What We Offer

• Competitive compensation with annual performance bonus eligibility

• Annual merit-based pay increases

• Automatic enrollment in a 401(k) at 3% pre-tax with 50% company match on the first 6% contributed

• Paid Time Off

• 10 paid company holidays

• Comprehensive medical, dental, vision, and life insurance coverage

• Professional development reimbursement

• Career growth opportunities

• Tuition reimbursement for children and childcare expense reimbursement

Schedule

• Full-time, on-site position (Monday–Friday, 8:00 AM – 5:00 PM)

KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.

Company Description

KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.